Events

Device Recall NXStage PureFlow SL SAK303 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 NxStage Medical, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60807
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0826-2012
  • 사례 시작날짜
    2011-12-14
  • 사례 출판 날짜
    2012-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106520
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Subsystem, proportioning - Product Code FKR
  • 원인
    Report of high conductivity failure alarms with the pureflow sl due to excess concentrate by weight in the product (sak) dialysate preparation system.
  • 조치
    On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and complete and return the DEVICE PRODUCT RECALL REPLY FORM even if they do not have any of the affected product on hand via postage-prepaid envelop provided. If you have any questions about this notice, contact NxStage Customer Support at 866-Nxstage ( 697-8243).

Device

Device Recall NXStage PureFlow SL SAK303
  • 모델명 / 제조번호(시리얼번호)
    Lot 1117911, Exp. 2013-09
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx || The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • 제조사 주소
    NxStage Medical, Inc., 439 S Union St Fl 5th, Lawrence MA 01843-2837
  • 제조사 모회사 (2017)
    Nxstage Medical Inc
  • Source
    USFDA